Evidence map›Paper›PMID 12867608›Full record

Trial reportThe New England journal of medicine2003

Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer.

Christine M Ribic, Daniel J Sargent, Malcolm J Moore, Stephen N Thibodeau, Amy J French, Richard M Goldberg, Stanley R Hamilton, Pierre Laurent-Puig, Robert Gryfe, Lois E Shepherd and 3 more

3 registry-linked trialsAbstract readClinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 947 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
947citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00014079 completednot on this map

Clinical Significance of Genetic Markers in Colon Cancer

TypeobservationalSponsorAlliance for Clinical Trials in OncologyRan1997 to 2005Enrolled675ConditionsColorectal CancerArmsDNA stability analysis, loss of heterozygosity analysis, microsatellite instability analysis
NCT03923335 not yet recruitingnot on this mapstarted 2019, after this paper: background citation

The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer

TypeobservationalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2019 to 2026Enrolled287ConditionsColorectal NeoplasmsArmsDNA methylation detection
NCT05031975 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Temozolomide and Irinotecan Consolidation in Patients With MGMT Silenced, Microsatellite Stable Colorectal Cancer With Persistence of Minimal Residual Disease in Liquid Biopsy After Standard Adjuvant Chemotherapy: the ERASE-TMZ Study

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2022 to 2024Enrolled35ConditionsColorectal CancerArmsIrinotecan, Temozolomide
3 · Its place in the literature

Who cites it

947 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. SEOM-GEMCAD-TTD clinical guidelines for the adjuvant treatment of colon cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Neoadjuvant Pembrolizumab in Localized Microsatellite Instability High/Deficient Mismatch Repair Solid Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  12. Trial
  13. Review
  14. Observational
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article

887 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Christine M RibicCentre for Cancer Genetics, Samuel Lunenfeld Research Institute, Toronto.
Daniel J Sargent
Malcolm J Moore
Stephen N Thibodeau
Amy J French
Richard M Goldberg
Stanley R Hamilton
Pierre Laurent-Puig
Robert Gryfe
Lois E Shepherd
Dongsheng Tu
Mark Redston
Steven Gallinger

Funding

ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI LENNON, ANNE MARIE · 1993 to 2022
$54.6M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
MOLECULAR GENETICS AND ADJUVANT THERAPY OF COLON CANCERU01CA060100 · NCI · JOHNS HOPKINS UNIVERSITY · PI HAMILTON, STANLEY R · 1993 to 1996
–
NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA25224NCI NIH HHS CA60100NCI NIH HHS CA62924NCI NIH HHS P50 CA062924NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA025224
6 · The paper itself

Abstract

backgroundColon cancers with high-frequency microsatellite instability have clinical and pathological features that distinguish them from microsatellite-stable tumors. We investigated the usefulness of microsatellite-instability status as a predictor of the benefit of adjuvant chemotherapy with fluorouracil in stage II and stage III colon cancer.

methodsTumor specimens were collected from patients with colon cancer who were enrolled in randomized trials of fluorouracil-based adjuvant chemotherapy. Microsatellite instability was assessed with the use of mononucleotide and dinucleotide markers.

resultsOf 570 tissue specimens, 95 (16.7 percent) exhibited high-frequency microsatellite instability. Among 287 patients who did not receive adjuvant therapy, those with tumors displaying high-frequency microsatellite instability had a better five-year rate of overall survival than patients with tumors exhibiting microsatellite stability or low-frequency instability (hazard ratio for death, 0.31 [95 percent confidence interval, 0.14 to 0.72]; P=0.004). Among patients who received adjuvant chemotherapy, high-frequency microsatellite instability was not correlated with increased overall survival (hazard ratio for death, 1.07 [95 percent confidence interval, 0.62 to 1.86]; P=0.80). The benefit of treatment differed significantly according to the microsatellite-instability status (P=0.01). Adjuvant chemotherapy improved overall survival among patients with microsatellite-stable tumors or tumors exhibiting low-frequency microsatellite instability, according to a multivariate analysis adjusted for stage and grade (hazard ratio for death, 0.72 [95 percent confidence interval, 0.53 to 0.99]; P=0.04). By contrast, there was no benefit of adjuvant chemotherapy in the group with high-frequency microsatellite instability.

conclusionsFluorouracil-based adjuvant chemotherapy benefited patients with stage II or stage III colon cancer with microsatellite-stable tumors or tumors exhibiting low-frequency microsatellite instability but not those with tumors exhibiting high-frequency microsatellite instability.

Indexed as

Analysis of VarianceAntimetabolites, AntineoplasticBase Pair MismatchChemotherapy, AdjuvantColorectal NeoplasmsDNA, NeoplasmDNA RepairFluorouracilFollow-Up StudiesHumansMicrosatellite RepeatsNeoplasm StagingPrognosisSurvival AnalysisAntimetabolites, AntineoplasticDNA, NeoplasmFluorouracil

Identifiers

PMID12867608
PMCPMC3584639

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.